Baltimore Vaccine Plant's Troubles Ripple Across 3 Continents

[BumRushDaShow]

Source: New York Times

WASHINGTON — Quality-control problems at a Baltimore plant manufacturing Covid-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world. Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there.

But millions of doses have been shipped abroad, including to Canada, the European Union and South Africa. Regulators in various countries are now working to ensure that those doses are safe after the disclosure in March that workers at the Baltimore plant accidentally contaminated a batch of Johnson & Johnson’s vaccine with the harmless virus used to manufacture AstraZeneca’s. Both vaccines were produced at the same site. The mistake forced Emergent to throw out up to 15 million Johnson & Johnson doses after tests showed that the batch failed to meet purity requirements.

E.U. officials, as well as those in Canada and South Africa, said there was no evidence that any of the doses they had received were tainted. But the problems identified in Baltimore have slowed their vaccination efforts while they perform additional quality assessments as a precaution. Some doses from a single batch of the vaccine produced at Emergent are being administered in Europe, without problem, officials said.

In addition, about six million to nine million more doses are now on hold there and in the other countries because they came from batches that were produced in the same manufacturing suite and over the same two-day period in late February when the contamination occurred, according to health officials familiar with the situation.The F.D.A. has now called into question the equivalent of about 70 million doses from the plant, most of it intended for domestic use, and may decide that none of that vaccine can be released in the United States, those officials said.


Read more: https://www.nytimes.com/2021/05/06/world/baltimore-vaccine-countries.html

[Ramsey Barner]

1. Para. 29: it was a Trump Administration fuckup

As The Times previously reported, the federal government last year banked on Emergent to be the main domestic manufacturer for both the Johnson & Johnson and AstraZeneca vaccines even as evidence of serious quality problems mounted.

Though the government awarded Emergent a $163 million contract in 2012 to ready the Baltimore plant to make vaccines in response to a pandemic, the company had not met a key requirement for demonstrating large-scale manufacturing ability as a June 2020 deadline neared. That month, however, federal officials nonetheless announced a new $628 million deal, most of it to reserve manufacturing capacity at the Baltimore plant for Covid-19 vaccine.

The company’s stock price soared, and its chief executive, Robert Kramer, boasted during a virtual conference for investors in March that profitability in 2020 had been “off-the-chart successful.” In a conference call with Wall Street analysts last week, Emergent’s chief financial officer announced “significant revenue growth and corresponding profitability” for the first quarter of this year and projected record revenues for 2021, driven largely by the company’s Covid-19 vaccine manufacturing deals.

[link:https://www.nytimes.com/2021/05/06/world/baltimore-vaccine-countries.html|